Institute for Safe Medication Practices, 916 Prince Street, Suite 102, Alexandria, VA, 22314, USA.
Department of Epidemiology, George Washington University Milken Institute School of Public Health, Washington, DC, USA.
Pharmaceut Med. 2020 Apr;34(2):135-140. doi: 10.1007/s40290-020-00329-w.
The US Food and Drug Administration (FDA) and other major regulators regularly issue safety advisories about licensed drugs with new adverse effects that have been documented through observational studies, clinical trials, and spontaneously reported adverse drug events.
To assess the possible effects of a representative group of FDA Drug Safety Communications on the reporting of the specific adverse effect featured in the advisory on new cases reported to the FDA Adverse Event Reporting System (FAERS).
We examined 16 FDA Drug Safety Communications issued from 2010 to 2015 that had not previously been the focus of advisories from regulators in the UK, Canada, or Australia. We compared the reports of the adverse effect in the 8 calendar quarters preceding the advisory and in the 4 quarters following. We measured change in reporting frequency by calculating the event reporting odds ratio (ROR) for the post-warning compared to the pre-warning periods. We defined a credible association of the advisory with increased reporting as a ROR ≥ 2.0 and p value of < 0.05 by Fisher's Exact Test.
We found statistically significant increased reporting for 4/16 advisories with RORs that ranged from 3.9 to 40.6. Three advisories had smaller but still statistically significant increases that were less than the ROR ≥ 2.0 threshold. For 7 advisories, we found no statistically significant changes in reporting.
No consistent pattern or effect was found on spontaneous reporting following these safety advisories. After results were available, we observed that some cases with the largest reporting increase also involved substantial numbers of legal claims. Changes in adverse event reporting following a warning need to be evaluated on a case-by-case basis.
美国食品和药物管理局（FDA）和其他主要监管机构定期发布有关新的不良影响的许可药物的安全性通告，这些新的不良影响是通过观察性研究、临床试验和自发报告的药物不良事件记录的。
评估 FDA 药物安全通讯的代表性群体对报告新案例的 FDA 不良事件报告系统（FAERS）中特定不良影响的可能影响，这些新案例是在咨询通告中特别指出的。
我们研究了 2010 年至 2015 年发布的 16 份 FDA 药物安全通讯，这些通讯之前并未成为英国、加拿大或澳大利亚监管机构咨询通告的重点。我们比较了咨询通告前 8 个日历季度和后 4 个季度的不良影响报告。我们通过计算警告后与警告前期间的事件报告比值比（ROR）来衡量报告频率的变化。我们将咨询通告与增加报告之间的可信关联定义为 ROR≥2.0 和 Fisher 精确检验的 p 值<0.05。
我们发现 4/16 份咨询通告的报告频率有统计学意义的增加，ROR 范围从 3.9 到 40.6。有 3 份咨询通告的增加幅度较小，但仍具有统计学意义，低于 ROR≥2.0 的阈值。对于 7 份咨询通告，我们没有发现报告频率有统计学意义的变化。
在这些安全性通告后，我们没有发现自发报告有一致的模式或影响。在结果可用后，我们观察到一些报告增加最多的案例也涉及大量法律索赔。需要逐个案例评估警告后不良事件报告的变化。
